NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JAPIC ID: JapicCTI-183842

Registered date:26/01/2018

A single-dose study of TMS-007 in patients with ischemic stroke (phase IIa study)

Basic Information

Recruitment status complete
Health condition(s) or Problem(s) studiedAcute ischemic stroke
Date of first enrollment21/2/2018
Target sample size90
Countries of recruitmentJapan
Study typeINTERVENTIONAL
Intervention(s)Intervention name : TMS-007 INN of the intervention : - Dosage And administration of the intervention : intravenous infusion ; 1, 3, and 6 mg/kg Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : intravenous infusion

Outcome(s)

Primary Outcomesafety Safety Adverse event, symptomatic intracranial hemorrhage, electrocardiogram, vital signs, laboratory tests, NIHSS, or mRS
Secondary Outcomeefficacy Efficacy MRS, NIHSS, rate of reperfusion, Blood marker [FDP, D-dimer, MMP-9, etc]

Key inclusion & exclusion criteria

Age minimum20
Age maximum87
GenderBOTH
Include criteriaJapanese who develop symptomatic cerebral infarction
Exclude criteria1 Patients who are suitable for rt-PA or endovascular treatment 2 High bleeding risk 3 High blood pressure or high blood glucose 4 Severe disease affecting the pathology of ischemic stroke 5 Pregnancy

Related Information

Contact

public contact
Name TMS Co., Ltd. Research & Development
Address 1-23-3-5F, Miyamachi, Fuchu-shi, Tokyo, Japan
Telephone -
E-mail -
Affiliation
scientific contact
Name TMS Co., Ltd. Research & Development
Address 1-23-3-5F, Miyamachi, Fuchu-shi, Tokyo, Japan
Telephone -
E-mail -
Affiliation